Drug factory · FDA FEI 3005554331
UFAG Laboratorien AG
Kornfeldstrasse 4, Sursee, Switzerland
No problems found at FDA's last inspection, Mar 14, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2012: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lofexidine | Tests it | Prasco Laboratories, Uswm, LLC | 66993-345, 78670-050 |
| Solriamfetol | Tests it | Axsome Therapeutics, Inc. | 81968-350, 81968-351 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2023 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 5, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 8, 2012 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 5, 2014 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Registered with FDA for: analysis.